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Certain Gel-Filled Teethers are Recalled

Luv N’ Care Ltd, a Monroe, Louisiana based corporation, is initiating a recall of their gel-filled teethers with the brand names “Nuby,” “Cottontails,” and “Playschool.” The products are being recalled because of a finding by the FDA that two lots contained Bacillus subtilis and Bacillus circulans in the gel. While generally these bacteria do not cause illness in adults, children have weakened immune systems and can get sick if the teether is punctured and the gel is accidentally ingested.

If the bacteria are ingested by a child, it can cause stomach pain, vomiting, diarrhea, and sometimes more serious disease. However, no illnesses have been reported to date. The company distributed the products through retail outlets nationwide, and have also been marketed on the internet. The company has discontinued production of the teethers and is urging consumers to return the teethers for a full refund.

The recall involves the following products:
UPC code Brand Name 48526-00451 Nuby48526-00452 Nuby48526-00453 Nuby48526-00454 Nuby48526-00455 Nuby48526-00459 Nuby48526-00467 Nuby48526-00472 Nuby48526-00473 Nuby48526-00482 Nuby48526-00483 Nuby48526-00487 Nuby48526-00490 Nuby48526-00519 Nuby48526-00521 Nuby41520-87115 Cottontails50428-91511 Playschool41520-91660 Cottontails

Consumers with questions may contact the company at 1-800-256-2399 ext. 3106 between 8 a.m. and 5 p.m. central time.

Adverse reactions experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.

For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172712.htm

See the FDA press release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172713.htm

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